Medicinal Products

DUROGESIC 12 micrograms / hour

Generic drug of the therapeutic class: Analgesics
Active ingredients: Fentanyl
laboratory: Janssen Cilag

Transdermal patch
Box of 5
All forms

Indication

In the adult

DUROGESIC is indicated for the treatment of severe chronic pain, which can only be adequately treated with opioid analgesics.

In the child

DUROGESIC is indicated for the long-term treatment of severe chronic pain in children over 2 years of age receiving opioid analgesics.

Dosage DUROGESIC 12 micrograms / hour transdermal patch Box of 5

In the adult

The dosage is individual and based on the patient's previous opioid treatments and takes into account:

· The possibility of habituation,

· The current general condition, the patient's medical condition, and

· The degree of severity of the disease.

The required dose of fentanyl is adjusted individually and should be evaluated regularly after each administration.

Patients receiving opioid therapy for the first time

Use the lowest dose DUROGESIC transdermal patch, 12 micrograms / hr for initiation of treatment. In very old or weak patients, opioid therapy should not be initiated with DUROGESIC because of their known sensitivity to opioid therapy. In these cases, it is preferable to initiate the treatment with low doses of morphine immediate release and prescribe DUROGESIC after determination of the optimal dosage.

Patients previously treated with opioids

When replacing oral or parenteral opioid therapy with fentanyl, the initial dose of fentanyl should be calculated as follows:

1. the amount of analgesic that has been required in the last 24 hours must be determined.

2. the sum thus obtained must be converted into the corresponding oral dose of morphine, using Table 1.

3. The corresponding dose of fentanyl should be determined as follows:

a) using Table 2 for patients requiring opioid rotation (conversion ratio of oral morphine to transdermal fentanyl equal to 150: 1)

b) using Table 3 for patients whose opioid treatment is stable and well tolerated (conversion ratio of oral morphine to transdermal fentanyl equal to 100: 1)

Table 1: Table of equi-analgesic doses of different opioids

All the doses indicated in this table are equivalent, in terms of analgesic effect, to 10 mg of parenteral morphine.

Equal-analgesic doses (mg)

Active substance

Parenteral (IM)

Oral way

Morphine

10

30 - 40

hydromorphone

1.5

7.5

oxycodone

10 - 15

20 - 30

methadone

10

20

levorphanol

2

4

oxymorphine

1

10 (rectal route)

diamorphine

5

60

pethidine

75

-

Codeine

-

200

buprenorphine

0.4

0.8 (sublingual route)

ketobemidone

10

20 - 30

Table 2: Recommended Initial Dose of Transdermal Fentanyl Based on Daily Oral Morphine Dose

(for patients requiring opioid rotation)

Oral dose of morphine (mg / 24 h)

Transdermal release of fentanyl

(Micrograms / h)

<44

12.5

45 - 134

25

135 - 224

50

225 - 314

75

315 - 404

100

405 - 494

125

495 - 584

150

585 - 674

175

675 - 764

200

765 - 854

225

855 - 944

250

945 - 1034

275

1035 - 1124

300

Table 3: Recommended Initial Dose of Transdermal Fentanyl Based on Daily Oral Morphine Dose

(for patients whose opioid treatment is stable and well tolerated)

Oral dose of morphine (mg / 24 h)

Transdermal release of fentanyl

(Micrograms / h)

<60

12.5

60 - 89

25

90 - 149

50

150 - 209

75

210 - 269

100

270 - 329

125

330 - 389

150

390 - 449

175

450 - 509

200

510 - 569

225

570 - 629

250

630 - 689

275

690 - 749

300

By combining several transdermal patches, a release of more than 100 micrograms of fentanyl per hour can be achieved.
Initial evaluation of the maximum analgesic effect of DUROGESIC should be performed 24 hours after patching. Indeed, the serum concentrations of fentanyl increase gradually during the first 24 hours following the application of the patch.

During the first 12 hours after DUROGESIC replacement, the patient continues to receive the previously prescribed analgesic at the same dose. For the next 12 hours, this analgesic is administered as needed.

Dose adjustment and maintenance treatment

The patch must be replaced every 72 hours. The dose should be adjusted case by case until effective analgesia is obtained. For patients in whom the analgesic effect drops significantly in the 48 to 72 hours after application, it may be necessary to repeat the fentanyl patch after 48 hours.

DUROGESIC 12 micrograms per hour is suitable for dose adjustment, for low dosages. If the analgesic effect is insufficient at the end of the initial application period, it is possible to increase the dose after 3 days until the desired effect for each patient is achieved. Normally, other dose adjustments should be done in increments of 25 micrograms / hour, although additional analgesic needs and pain intensity of the patient should be considered.

Patients may need, at times, additional doses of a short-acting analgesic in case of paroxysmal pain.

Additional or different analgesic methods, or the administration of different opioids should be considered when the DUROGESIC dose exceeds 300 micrograms / hour.

Withdrawal symptoms have been reported after prolonged treatment with morphine with transdermal fentanyl, despite good analgesic efficacy. If symptoms of withdrawal occur, it is recommended that they be treated with low doses of short-acting morphine.

Modification or discontinuation of treatment

If discontinuation of DUROGESIC therapy is required, replacement with other opioids should be progressive starting with a low dose and gradually increasing the dose. Indeed, fentanyl levels decrease gradually after patch removal and it takes at least 17 hours for the serum fentanyl concentration to decrease by 50%.

In general, opioid analgesic therapy should be discontinued gradually to avoid withdrawal symptoms (nausea, vomiting, diarrhea, anxiety, and muscle tremor). Conversion tables 2 and 3 should not be used for the transition from DUROGESIC treatment to morphine.

Administration mode

Immediately after removing the patch from the bag and peeling off the nonstick layer, apply the transdermal patch to a glabrous area of ​​the upper body skin (chest, back, upper arm). To remove hair, use scissors and not a razor. Before application, wash the skin thoroughly with clean water (without cleansers) and dry thoroughly. Then apply the transdermal patch by lightly pressing the palm of your hand for about 30 seconds. The skin area to which the patch is applied should not have microlesions (eg due to radiotherapy or shaving) or irritation.

Because the transdermal patch is protected by an impermeable posterior outer film, it can be worn in the shower.

It is sometimes necessary to provide additional fixation of the patch.

If the dose is gradually increased, the required active area may reach a value beyond which further increase is no longer possible.

After application of the device, do not discard the bag because it has in its label back, a used device recovery system (see section Instructions for use, handling and disposal ).

Duration of administration

It is necessary to renew the patch after 72 hours. If it is necessary to renew it more quickly in a given patient, it is necessary to wait at least 48 hours for renewal otherwise the average concentrations of fentanyl may become excessive. It is necessary to change the site of application during each renewal of the patch. An interval of 7 days must be observed before applying a new patch on the same area of ​​the skin. The analgesic effect may persist for some time after removal of the transdermal patch.

If traces of the transdermal patch remain on the skin after removal, they can be removed using plenty of soap and water. Never use alcohol or other solvents for cleaning as they may penetrate the skin due to the effect of the patch.

Use in elderly patients

Elderly patients should be closely monitored and the dose reduced if necessary (see sections Warnings and Precautions and Pharmacokinetic Properties ).

Hepatic and renal insufficiency

In patients with hepatic or renal impairment, careful monitoring and, if necessary, dose reduction should be performed (see Warnings and Precautions ).

In the child

Children aged 16 or over

Refer to the dosage in adults.

Children aged 2 to 16

Administration mode

In young children, the patch should be applied preferentially to the upper back to prevent the child from removing the patch.

Dosage

DUROGESIC should be administered only to children aged 2 to 16 years who are stable to stable opioid intolerance and given a dose equivalent to at least 30 mg oral morphine daily.

To calculate the dose of DUROGESIC to be administered from the oral morphine dose per 24 hours, use the conversion table below, provided as an indication.

DUROGESIC doses recommended as a guideline based on morphine doses / 24 hours 1

Oral way
Morphine dose / 24 hours
(Mg / day)

DUROGESIC
Transdermal patch in micrograms / h

In children 2

30 - 44

12

45 - 134

25

1 In clinical studies, these oral morphine dose ranges were used as a basis for conversion to DUROGESIC.

2 For doses of morphine greater than 134 mg / 24 hours, the conversion table to be used is the same for children and adults.

Data from clinical trials are limited in children receiving more than 90 mg oral morphine daily. In studies in children, the required transdermal fentanyl dose was calculated as follows: 30 mg to 45 mg oral morphine per day or equivalent opioid dose corresponds to a DUROGESIC transducer 12 μg / h. This conversion table in children applies only to the passage of oral morphine (or its equivalent) DUROGESIC, transdermal device. The conversion table should not be used for switching from DUROGESIC to morphine or other opioids due to the risk of overdose.

The analgesic effect of the first dose of DUROGESIC is not optimal during the first 24 hours. Therefore, it is recommended to continue analgesics previously used during the first 12 hours after the first patch is applied. During the next 12 hours, these analgesics can be used according to the needs of the patient.

Since peak plasma concentrations of fentanyl occur after 12 to 24 hours of treatment, monitoring of the occurrence of adverse events, particularly bradycardia, bradypnea and hypoventilation, is recommended for at least 48 hours after initiation of treatment with DUROGESIC or after a dose increase (see also Warnings and Precautions ).

Dosage adjustment and maintenance treatment

In case of insufficient analgesic effect of DUROGESIC, it may be necessary to administer additional doses of morphine or other short-acting opioid. Depending on the additional analgesic requirements and the painful condition of the child, it may be necessary to increase the dosage. Dosage adjustments should be performed in increments of 12 μg / h.
ANSM ALERT on 25/06/2014:

Cases of accidental exposure to transdermal fentanyl, particularly in children, have been reported. Some have had a fatal outcome.

Situations at

Precautions to avoid risk situations

Conduct to take in case

risk

accidental exposure

Transfer of the treated patient's patch to a third party

- Give priority to covered application sites.

- Regularly check the good adhesion of the patch.

- Pay particular attention, especially during sleep or close physical contact.

- Removing the patch from the person being accidentally exposed,

- Immediate medical consultation.

Accidental ingestion (especially in children)

- a used patch

- Fold the patch back on itself as the used patches still contain a significant amount of active ingredient.

- Then place the patch in the recovery system provided, place it out of reach of children and return it to the pharmacy.

- a patch that has detached from the treated patient

- a patch removed by the treated child

- In general, favor covered application sites that are difficult to access. In addition, in children, favor the upper part of the back to avoid withdrawal by the child.

- Ensure the good adhesion of the patch during the application (cut the superfluous hair, wash the area with clean water, without cleaning product, ensure that it is perfectly dry before application) and regularly after the pose.

Immediate medical consultation

Against indications

· Hypersensitivity to the active substance or to any of the excipients.

· Acute or postoperative pain as dose adjustment is not possible during short-term use.

· Serious disturbance of the central nervous system.

· In children (2 to 16 years old): patients who have never received opioids or are opioid-intolerant.

Durogesic side effects

The frequency of adverse reactions is defined as follows: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1/100), rare (≥ 1/10 000, <1/1000), very rare (<1 / 10, 000)

The most serious side effect of fentanyl is respiratory depression.

Heart conditions

Uncommon: tachycardia, bradycardia.

Rare: arrhythmia.

Nervous system disorders

Very common: headache, dizziness.

Uncommon: tremor, paresthesia, abnormal language.

Very rare: ataxia, seizures (including clonic seizures and grand mal seizures).

Eye disorders

Very rare: amblyopia.

Respiratory, thoracic and mediastinal disorders

Uncommon: dyspnoea, hypoventilation.

Very rare: respiratory depression, apnea.

Gastrointestinal disorders

Very common: nausea, vomiting, constipation.

Frequent: dryness of the mouth, dyspepsia.

Uncommon: diarrhea

Rare: hiccups.

Very rare: painful flatulence, ileus.

Renal and urinary disorders

Uncommon: urine retention.

Very rare: cystalgie, oliguria.

Skin and subcutaneous tissue disorders

Very common: sweating, pruritus.

Frequent: skin reactions at the application site.

Uncommon: exanthema, erythema.

Rash, erythema and pruritus usually disappear within a day after removal of the patch.

Vascular disorders

Uncommon: hypertension, hypotension.

Rare: vasodilatation.

General disorders

Rare: edema, feeling cold.

Immune system disorders

Very rare: anaphylaxis.

Psychiatric disorders

Very common: drowsiness.

Common: sedation, nervousness, loss of appetite

Uncommon: euphoria, amnesia, insomnia, hallucinations, agitation.

Very rare: delusions, states of excitement, asthenia, depression, anxiety, confusion, sexual disorders, withdrawal syndrome.

Other adverse effects

No information (impossible to evaluate in the light of available data): Prolonged use of fentanyl can lead to the development of habituation and physical and mental dependence. After DUROGESIC relays other opioid analgesics or after stopping therapy, patients may experience opioid withdrawal syndrome (for example, nausea, vomiting, diarrhea, anxiety, and chills).

In children (2 to 16 years)

The adverse event profile in children and adolescents treated with DUROGESIC was similar to that seen in adults. In children, no risk has been identified greater than that expected when opioids are used in the treatment of cancer-related pain, and there does not appear to be any specific pediatric risk associated with it. the use of DUROGESIC in children from 2 years as soon as it is used according to the defined recommendations.

The most commonly reported adverse reactions in clinical trials in children were fever, vomiting, and nausea.

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